Study of Immunity at the Genital Mucosa of HIV-1 Infected and Healthy Women (MUCOVAC)

This study has been terminated.

(Results of primary outcome are not satisfactory in terms of RNA quality)

Sponsor:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

ClinicalTrials.gov Identifier:

NCT01715103

First Posted: October 26, 2012

Last Update Posted: July 1, 2015

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Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Current knowledge on mucosa, especially genitals in women, however, remain inadequate, especially regarding defense mechanisms and possibilities for a vaccine to induce an active immune response at mucosal front door of the most pathogens. Induction of mucosal immune response has emerged as a research priority research prophylactic vaccine.The development of strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of specific and innate immune mechanisms involved in this transmission.

MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of cervicovaginal samples of women infected or not infected with HIV-1. We also assess tolerance samples taken by cytobrush and cervicovaginal washings, efficiency and reproducibility of the sample by cytobrush and cervicovaginal lavage for transcriptomic analysis, measurement of cytokines by Luminex technology, quantification of IgG and IgA. In blood we will determine the phenotype of B cells and Tfh cell frequency (T follicular helper) and quantification of serum immunoglobulins and will perform a transcriptomic analysis of blood cells. Finally we will make correlations with the observed responses at the genital mucosa.

This pathophysiological exploratory study will be performed in 20 women infected with HIV-1 and 20 healthy women recruited from two centers in France and will include a screening visit and two visits M0 and M1 during which mucous and blood samples will be performed.

The results of the study will capitalize skills in biology mucosa, using powerful tools to assess mucosal immunological parameters.

Efficiency of collection by washing (Ig rate > 1μg/ml) and quality of cells collected by cytobrush and of cell pellet from washes for a transcriptomic analysis (the quantity and quality of RNA: RIN (RNA integrity number) > 5 and an amount of RNA 50> ng)

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Ages Eligible for Study:

18 Years to 45 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Free, informed and signed consent

Person affiliated or beneficiary of a social security system or the Universal Health Coverage

Female

No menopausal, aged 18 to 45 years,

Under oral contraceptive or implant

Urine pregnancy test negative

HBsAg and HCV serology negative

Cervicovaginal smear normal older than one year,

Normal vaginal smear dated within one year

For healthy women

* HIV serology negative

For infected women

HIV-1 infection checked by western-blot and/or the detection of HIV-RNA

CD4+ T cells >350/mm3 (several tests, since 6 months)

Viral load <40 copies/ml since 6 months

Treated with antiretroviral drugs since 6 months

Exclusion Criteria:

Significant history of vaginal pathology (malignancy, prolapse)

Hysterectomy, conization

History of abnormal Pap smear in the previous year (ASC-US, AG-US and LSIL and high grade according to Bethesda).

Breakthrough bleeding;

Clinical symptoms suggestive of genital infection within 10 days prior to the examination of the study,

Antibiotic systemically within 10 days prior to the examination of the study,

Immunosuppressive or immunomodulatory treatment in the last six months and corticosteroids (> 20 mg / day for 5 days) in last 3 months